(382 days)
These dressings are intended for OTC use on wounds such as:
- Minor cuts and grazes .
- Minor scalds and burns .
- Insect bites .
MedTrade Products Antiseptic Barrier Hydrogel Dressings are contraindicated for:
- . Third degree burns
MedTrade Product's Antiseptic Barrier Hydrogel Dressings consist of an Antiseptic Hydrogel, which is over 70% pure water. Effective antiseptic barrier protection of the dressing against microbes and microbial contamination is provided by the antiseptic barrier hydrogel and adhesive film cover of the dressing is made from a special Antiseptic Barrier hydrogel formulation which not only has a high water activity (a measure of cooling) but is also capable of absorbing substantial quantities of fluid. This makes it especially suitable for use on burns with minimal risk of maceration. The Antiseptic Barrier hydrogel dressings are highly conformable, soft, absorbent, sterile, primary wound dressings of a gelatinous mass which provides a moist healing environment.
The provided 510(k) summary for MedTrade Product's Antiseptic Barrier Hydrogel Dressings does not contain information typically found in acceptance criteria or a detailed study report for device performance in the context of diagnostic or AI-enabled medical devices. This document is for a medical device (a dressing) and focuses on its substantial equivalence to a predicate device and its physical and chemical properties and general safety, rather than statistical performance metrics like sensitivity, specificity, accuracy, or reader improvement.
Therefore, many of the requested categories are not applicable or cannot be extracted from this type of regulatory submission. The information that can be inferred or directly stated is provided below.
Acceptance Criteria and Study for MedTrade Product's Antiseptic Barrier Hydrogel Dressings
This 510(k) submission primarily demonstrates substantial equivalence to a predicate device (MedTrade Product's Hydrogel Island Dressings K002504) and outlines the product's physical characteristics, intended use, and general safety testing. It does not include performance data or acceptance criteria related to diagnostic accuracy, reader performance improvement, or AI algorithm standalone performance, as these are not relevant for this type of medical dressing.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic / Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence to Predicate | Device is substantially equivalent in design, composition, and function to MedTrade Product's Hydrogel Island Dressings K002504, with the addition of an antiseptic to provide an antiseptic barrier hydrogel. | The FDA determined the device is substantially equivalent to legally marketed predicate devices. |
| Antiseptic Barrier Activity | (Implicit) Demonstrate "Antiseptic Barrier activity". | "MedTrade Products Antiseptic Barrier Hydrogel has been shown to have 'Antiseptic Barrier activity'." (No specific metric or threshold provided in this document). |
| Sterilization | Meet requirements of ANS/AAMI/ISO11137 - 1995 and AAMI TIR8-1991 for Method 1 dosimetric release with a sterility assurance level of 10⁻⁶. | Product is gamma irradiated in accordance with the specified standards for qualification for Method 1 for dosimetric release with a sterility assurance level of 10⁻⁶. Supplied sterile. |
| Biocompatibility (Dermal Irritation) | (Implicit) Successful completion per ISO/Tripartite guidelines. | Biocompatibility testing including Dermal Irritation has been successfully completed per ISO/Tripartite guidelines. |
| Biocompatibility (Dermal Sensitization) | (Implicit) Successful completion per ISO/Tripartite guidelines. | Biocompatibility testing including Dermal Sensitization has been successfully completed per ISO/Tripartite guidelines. |
| Biocompatibility (Cytotoxicity) | (Implicit) Successful completion per ISO/Tripartite guidelines. | Biocompatibility testing including Cytotoxicity has been successfully completed per ISO/Tripartite guidelines. |
| Biocompatibility (Acute Systemic Toxicity) | (Implicit) Successful completion per ISO/Tripartite guidelines. | Biocompatibility testing including Acute Systemic Toxicity has been successfully completed per ISO/Tripartite guidelines. |
| Biocompatibility (Hemocompatibility/Hemolysis) | (Implicit) Successful completion per ISO/Tripartite guidelines. | Biocompatibility testing including Hemocompatibility/Hemolysis has been successfully completed per ISO/Tripartite guidelines. |
| Indicated Uses (OTC) | Safe and effective for OTC use on minor cuts & grazes, minor scalds & burns, and insect bites. | Indicated for OTC use on minor cuts & grazes, minor scalds & burns, and insect bites. (FDA's substantial equivalence determination implies acceptance of this indication). |
| Contraindications | Clearly define any contraindications. | Contraindicated for: Third degree burns. |
| Composition (Hydrogel) | High water content medical grade hydrophilic polymer. | High water content medical grade hydrophilic polymer. (Matches predicate). |
| Composition (Backing) | Self Adhesive Film. | Self Adhesive Film. (Matches predicate). |
| Composition (Adhesive) | Medical grade pressure sensitive adhesive. | Medical grade pressure sensitive adhesive. (Matches predicate). |
| Composition (Adhesive Coverage) | 100% on backing. | 100% on backing. (Matches predicate). |
| Packaging | Printed Pouch. | Printed Pouch. (Matches predicate). |
2. Sample size used for the test set and the data provenance:
- This document does not specify a "test set" in the context of evaluating diagnostic performance.
- Biocompatibility testing would have involved specific animal and/or in-vitro samples, but the sample sizes and detailed data provenance (e.g., country of origin, retrospective/prospective) are not disclosed in this summary.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Not applicable as this is not a diagnostic device involving expert interpretation of data. Ground truth, in this context, would relate to the successful completion of specific standardized tests (e.g., sterility, biocompatibility), which are typically pass/fail criteria against established scientific guidelines, not expert consensus.
4. Adjudication method for the test set:
- Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable as this is not an AI-enabled diagnostic device or software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is not an algorithm or AI device.
7. The type of ground truth used:
- For sterility: Laboratory testing against a Sterility Assurance Level (SAL) of 10⁻⁶ per specified ISO/AAMI standards.
- For biocompatibility: Successful completion of tests (Dermal Irritation, Dermal Sensitization, Cytotoxicity, Acute Systemic Toxicity, Hemocompatibility/Hemolysis) based on ISO/Tripartite guidelines.
- For antiseptic barrier activity: "Shown to have 'Antiseptic Barrier activity'" - the specific method or ground truth definition is not provided in this summary but would typically involve standardized microbiological challenge tests.
8. The sample size for the training set:
- Not applicable as this is not an AI-enabled device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
N/A